Lumicell announced that an FDA advisory committee voted in support of the benefit-risk profile of its LumiSight offering. LumiSight, an optical imaging agent, works in combination with the Lumicell direct visualization system (DVS) in breast cancer imaging. The combination product — a fluorescence-guided surgical imaging tool — detects residual cancer in real-time during a lumpectomy. […]
Oncology
GE Healthcare’s AI models can predict patient responses to immunotherapy
GE HealthCare today announced data showing its AI models’ ability to accurately predict patient responses to immunotherapies. The study collected clinical data to accurately forecast the effectiveness and toxicity of cancer immunotherapy. Data demonstrated accuracy between 70% and 80% with the AI models in a pan-cancer cohort. Investigators published outcomes in the Journal of Clinical […]
Medtronic wins FDA clearance for bone tumor ablation tech
Medtronic announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system. The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to […]
FDA clears surgical guidance system from Merit Medical
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system. Scout MD broadens the South Jordan, Utah–based company’s oncology portfolio. Merit designed the system to enhance the diagnosis and treatment of breast cancer, as well as other soft tissue cancers. The system includes the Scout radar […]
Vessi Medial raises $16.5M for cryotherapy for bladder cancer
Vessi Medical announced today that it closed a Series A financing round worth $16.5 million to support its cryotherapy technology. Misgav, Israel-based Vessi develops its technology to treat non-muscle invasive bladder cancer (NMIBC). It could provide a therapeutic alternative to transurethral resection of bladder tumor (TURBT), the current first-line therapy. Vessi believes its bladder-specific, proprietary […]
Carthera enrolls first patient in ultrasound drug delivery trial
Carthera announced today that it enrolled the first patient in the SONOBIRD pivotal trial for its SonoCloud device. Paris, France-based Carthera designed SonoCloud to treat a wide range of brain disorders. The device emits ultrasound to temporarily increase the permeability of blood vessels in the brain, improving therapeutic molecule delivery. After implantation in the skull, […]
FDA to reassess cryoablation tech for destroying tumors from IceCure Medical
IceCure Medical (Nadsaq:ICCM) announced today that the FDA responded affirmatively to a request for supervisory review. This follows the agency’s 2022 denial of IceCure’s de novo classification request for its ProSense cryoablation system. The Caesarea, Israel-based company sought clearance for ProSense to treat patients with early-stage, low-risk breast cancer. FDA’s affirmative response reopens the de […]
RenovoRx closes $6.1M private placement
RenovoRx announced today that it closed a private placement bringing in gross proceeds of approximately $6.1 million. Los Altos, California-based RenovoRx develops precision oncology therapies based on a local drug delivery platform. Closing this funding round extends the company’s cash runway as it conducts its pivotal TIGer-PaC Phase III clinical trial. It expects the funds […]
Noah Medical hits 500-case mark with Galaxy surgical robot
Noah Medical today announced the 500th use of its Galaxy surgical robotic system for robotic-assisted bronchoscopy in the U.S. San Carlos, California-based Noah Medical designed Galaxy and its accessories to provide bronchoscopic visualization and access. These capabilities provide diagnostic and therapeutic procedures in patient airways. The system features advanced imaging technologies that provide real-time location […]
FDA clears Kallisio’s 3D-printed oral insert for radiation therapy
Kallisio recently announced that the FDA has cleared its 3D-printed Stentra, used to protect head and neck cancer patient’s healthy tissue during radiation therapy. Stentra is fabricated of bio-compatible nylon materials (nylon ISO 10993-1), using 3D SLS printing technology. Baltimore-based Kallisio says Stentra directs radiation to the target tumor area while reducing the harmful impact […]
FDA clears DermaSensor AI-powered skin cancer detection device
DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system. Miami-based DermaSensor develops a handheld device that uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound. […]